First quarter revenues increased 23% sequentially to
Cholbam™ received
- Net product sales for the first quarter 2015 were
$17.4 million - Non-GAAP operating income for the first quarter 2015 was
$1.4 million , compared to a non-GAAP operating loss of$17.5 million for the same period in 2014 - Cash, cash equivalents and marketable securities as of
March 31, 2015 totaled$126.3 million
"The first quarter proved to be a very productive start to 2015, as we continued to execute against our strategy," said
Quarter Ended
Net product sales for the first quarter of 2015 were
Selling, general and administrative expenses for the first quarter of 2015 were
Research and development expenses for the first quarter of 2015 were
Total other income for the first quarter of 2015 was
Income tax benefit of approximately
Net income for the first quarter of 2015 was
Commercial Product Updates
Thiola® (tiopronin)
- As of
May 11, 2015 , more than 725 patients were receiving Thiola® therapy. Retrophin is expanding its salesforce from 16 to 24 members, which will allow coverage of an additional 500 to 600 potential prescribers. These efforts are expected to continue the strong momentum created thus far in the re-launch.
Cholbam™ (cholic acid)
- Cholbam™ shipped to the first commercial patient in April and the Company has more than a dozen patients already on therapy.
- In addition to initiating the transition of approximately 30 patients from the clinical trial extension to commercial therapy, several new patients have also been identified and begun Cholbam™ treatment.
Chenodal® (chenodeoxycholic acid)
Retrophin continues to have a constructive dialogue with theU.S. Food and Drug Administration (FDA) to determine an acceptable pathway for the addition of cerebrotendinous xanthomatosis (CTX) to the Chenodal® label.- In April,
Retrophin initiated start-up activities for its screening study of the prevalence of CTX in pediatric and adolescent patients with idiopathic bilateral cataracts. The study will include approximately 50 centers for testing, with the goal of screening 500 total patients.
Pipeline Updates
Sparsentan
- The Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS) continues to enroll toward the target of 100 patients by year-end 2015.
- The Data Monitoring Committee recently met and unanimously approved continuation of DUET enrollment into the highest dose cohort.
RE-024
- The Company filed an Investigational New Drug Application (IND) in the first quarter of 2015 to support a Phase 1 study of RE-024 in healthy volunteers. The
FDA notifiedRetrophin onApril 28, 2015 that the Phase 1 study may proceed. Retrophin has initiated the screening of healthy volunteers for its Phase 1 trial of safety and tolerability of single doses of RE-024. Subjects are expected to begin dosing in the second quarter of 2015.- On
May 5, 2015 , theFDA Office of Orphan Products Development (OOPD) granted orphan drug designation to RE-024 for the treatment of pantothenate kinase-associated neurodegeneration (PKAN).
RE-034
Retrophin continues development of RE-034, which may include initiation of IND-enabling studies in 2015.
Conference Call Information
Use of Non-GAAP Financial Measures
To supplement Retrophin's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP adjusted financial measures in this press release and the accompanying tables. The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures, and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Retrophin's management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. In addition,
Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future the Company may exclude other items, or cease to exclude items that it has historically excluded, for purposes of its non-GAAP financial measures; Because of the non-standardized definitions, the non-GAAP financial measures as used by the Company in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the Company's competitors and other companies.
As used in this press release, (i) the historical non-GAAP net income (loss) measures exclude from GAAP net income (loss), as applicable, intangible asset amortization, stock-based compensation expense, executive severance charges, transaction and license fees, change in fair value of derivative liabilities, depreciation expense, non-cash interest and finance expenses; adjust the income tax provision to the estimated amount of taxes that are payable in cash; (ii) the historical non-GAAP SG&A expense measures exclude from GAAP SG&A expenses, as applicable, intangible asset amortization, stock-based compensation expense, executive severance charges, transaction and license fees, legal fee and settlements, and depreciation expense; (iii) the historical non-GAAP R&D expense measures exclude from GAAP R&D expenses, as applicable, intangible asset amortization, stock-based compensation expense, transaction and license fees and depreciation expense.
About
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the Company's business and finances in general, as well as risks and uncertainties associated with the Company's pre-clinical and clinical stage pipeline as well as its sales and marketing strategies. Specifically, the risks and uncertainties the Company faces with respect to its pre-clinical and clinical stage pipeline include risk that the Company's research programs will not identify pre-clinical candidates for further development and risk that the Company's clinical candidates will not be found to be safe or effective. Specifically, the Company faces risk that the sparsentan Phase 2 clinical trials will fail to demonstrate that sparsentan is safe or effective; risk that the sparsentan Phase 2 program will be delayed for regulatory or other reasons; risk that the Company will be unable to initiate and/or complete Phase 1 clinical trials of RE-024, risk that RE-024 will not progress to Phase 2 or later clinical trials for safety, regulatory or other reasons; risk that the Company will be unable to file an IND for RE-034 or initiate Phase 1 clinical trials for regulatory or other reasons, and for each of the programs risk associated with enrollment of clinical trials for rare diseases. The Company faces risks associated with market acceptance and competition for its marketed products. The Company faces risk that it will be unable to raise additional funding required to complete development of any or all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company's filings with the
CONSOLIDATED BALANCE SHEETS | ||||||||||||||||||
|
|
|||||||||||||||||
Assets | ||||||||||||||||||
Current assets: | ||||||||||||||||||
Cash | $ | 120,174,877 | $ | 18,204,282 | ||||||||||||||
Marketable securities | 6,159,962 | 9,556,098 | ||||||||||||||||
Accounts receivable, net | 8,162,535 | 7,959,411 | ||||||||||||||||
Inventory, net | 1,718,365 | 800,507 | ||||||||||||||||
Pediatric priority review voucher, held for sale | 96,250,000 | - | ||||||||||||||||
Prepaid expenses and other current assets | 1,077,355 | 813,364 | ||||||||||||||||
Total current assets | 233,543,094 | 37,333,662 | ||||||||||||||||
Property and equipment, net | 618,620 | 670,796 | ||||||||||||||||
Security deposits | 337,014 | 337,014 | ||||||||||||||||
Restricted cash | 40,000 | 40,000 | ||||||||||||||||
Other asset | 1,987,364 | 1,888,035 | ||||||||||||||||
Intangible assets, net | 169,835,098 | 94,265,530 | ||||||||||||||||
Goodwill | 935,935 | 935,935 | ||||||||||||||||
Deferred tax asset | 8,691,307 | - | ||||||||||||||||
Total assets | $ | 415,988,432 | $ | 135,470,972 | ||||||||||||||
Liabilities and Stockholders' Equity (Deficit) | ||||||||||||||||||
Current liabilities: | ||||||||||||||||||
Deferred technology purchase liability | $ | 1,000,000 | $ | 1,000,000 | ||||||||||||||
Accounts payable | 5,913,027 | 7,124,330 | ||||||||||||||||
Accrued expenses | 19,346,699 | 27,882,995 | ||||||||||||||||
Other liability | 943,615 | 938,209 | ||||||||||||||||
Acquisition-related contingent consideration | 2,880,577 | 2,117,565 | ||||||||||||||||
Derivative financial instruments, warrants | 63,390,000 | 27,990,000 | ||||||||||||||||
Deferred income tax liability | 8,691,307 | - | ||||||||||||||||
Note payable | - | 40,485,452 | ||||||||||||||||
Total current liabilities | 102,165,225 | 107,538,551 | ||||||||||||||||
Convertible debt | 43,439,333 | 43,287,814 | ||||||||||||||||
Note payable | 40,803,627 | - | ||||||||||||||||
Other liability | 12,294,520 | 12,234,513 | ||||||||||||||||
Acquisition-related contingent consideration, less current portion | 48,718,710 | 9,519,662 | ||||||||||||||||
Deferred income tax liability, net | - | 141,151 | ||||||||||||||||
Total liabilities | 247,421,415 | 172,721,691 | ||||||||||||||||
Commitments and contingencies | ||||||||||||||||||
Stockholders' Deficit: | ||||||||||||||||||
Preferred stock Series A |
||||||||||||||||||
authorized; 0 issued and outstanding | - | - | ||||||||||||||||
Common stock |
||||||||||||||||||
34,845,450 and 26,428,071 issued and 34,845,450 and |
||||||||||||||||||
26,048,480 outstanding, respectively |
3,485 | 2,643 | ||||||||||||||||
Additional paid-in capital | 310,210,811 | 140,850,551 | ||||||||||||||||
Treasury stock, at cost, none and 379,591, respectively | - | (3,214,608 | ) | |||||||||||||||
Accumulated deficit | (142,734,440 | ) | (179,174,858 | ) | ||||||||||||||
Accumulated other comprehensive income | 1,087,161 | 4,285,553 | ||||||||||||||||
Total stockholders' equity (deficit) | 168,567,017 | (37,250,719 | ) | |||||||||||||||
Total liabilities and stockholders' equity (deficit) | $ | 415,988,432 | $ | 135,470,972 | ||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | |||||||||||||||||
Three months ended |
|||||||||||||||||
2015 | 2014 | ||||||||||||||||
(unaudited) | (restated) | ||||||||||||||||
Net product sales | $ | 17,371,800 | $ | 27,900 | |||||||||||||
Operating expenses: | |||||||||||||||||
Cost of goods sold | 274,447 | 900 | |||||||||||||||
Research and development | 10,346,456 | 6,942,323 | |||||||||||||||
Selling, general and administrative | 14,855,340 | 15,146,346 | |||||||||||||||
Total operating expenses | 25,476,243 | 22,089,569 | |||||||||||||||
OPERATING LOSS | (8,104,443 | ) | (22,061,669 | ) | |||||||||||||
OTHER INCOME (EXPENSE): | |||||||||||||||||
Gain on sale of asset | 204,198 | - | |||||||||||||||
Interest income (expense), net | (3,798,533 | ) | 536 | ||||||||||||||
Finance expense | (600,000 | ) | - | ||||||||||||||
Realized gain on sale of marketable securities, net | 107,368 | 4,664 | |||||||||||||||
Change in fair value of derivative instruments-loss | (36,752,960 | ) | (53,613,802 | ) | |||||||||||||
Bargain purchase gain | 48,578,208 | - | |||||||||||||||
Total other income (expense), net | 7,738,281 | (53,608,602 | ) | ||||||||||||||
LOSS BEFORE INCOME TAXES | (366,162 | ) | (75,670,271 | ) | |||||||||||||
Income tax benefit (provision) | 40,021,151 | (65,376 | ) | ||||||||||||||
NET INCOME (LOSS) | $ | 39,654,989 | $ | (75,735,647 | ) | ||||||||||||
PER SHARE DATA: | |||||||||||||||||
Net income (loss) per common share, basic | $ | 1.46 | $ | (3.25 | ) | ||||||||||||
Net income (loss) per common share, diluted | $ | 1.32 | $ | (3.25 | ) | ||||||||||||
Weighted average common shares outstanding, basic | 27,157,883 | 23,334,967 | |||||||||||||||
Weighted average common shares outstanding, diluted | 30,380,694 | 23,334,967 | |||||||||||||||
Comprehensive Income (Loss): | |||||||||||||||||
Net income (loss) | $ | 39,654,989 | $ | (75,735,647 | ) | ||||||||||||
Unrealized gain (loss) | (3,198,391 | ) | 622,076 | ||||||||||||||
Comprehensive Income (loss) | $ | 36,456,598 | $ | (75,113,571 | ) | ||||||||||||
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | |||||||||||||||||
(unaudited) | |||||||||||||||||
Three Months Ended |
|||||||||||||||||
2015 | 2014 | ||||||||||||||||
GAAP OPERATING LOSS | $ | (8,104,443 | ) | $ | (22,061,669 | ) | |||||||||||
R&D Operating Expense | (10,346,456 | ) | (6,942,323 | ) | |||||||||||||
Stock Compensation | 2,219,698 | 547,733 | |||||||||||||||
Transaction & license fees | 150,000 | 868,198 | |||||||||||||||
Amortization & Depreciation | 220,916 | 242,720 | |||||||||||||||
Subtotal non-GAAP items | 2,590,614 | 1,658,651 | |||||||||||||||
NON-GAAP R&D EXPENSE | (7,755,842 | ) | (5,283,672 | ) | |||||||||||||
SG&A Operating Expense | (14,855,340 | ) | (15,146,346 | ) | |||||||||||||
Legal Expense (A) | 1,963,228 | - | |||||||||||||||
Stock Compensation | 3,353,580 | 2,857,143 | |||||||||||||||
Amortization & Depreciation | 1,557,788 | 13,218 | |||||||||||||||
Subtotal non-GAAP items | 6,874,596 | 2,870,361 | |||||||||||||||
NON-GAAP SG&A EXPENSE | (7,980,744 | ) | (12,275,985 | ) | |||||||||||||
Subtotal non-GAAP items | 9,465,210 | 4,529,012 | |||||||||||||||
NON-GAAP OPERATING INCOME (LOSS) | 1,360,767 | (17,532,657 | ) | ||||||||||||||
GAAP NET INCOME /(LOSS) | 39,654,989 | (75,735,647 | ) | ||||||||||||||
Non-GAAP Operating Loss Adjustments | 9,465,210 | 4,529,012 | |||||||||||||||
Finance Expense | 1,650,000 | - | |||||||||||||||
Change in fair value of derivative instruments-loss | 36,752,960 | 53,613,802 | |||||||||||||||
Bargain purchase (gain), net (A) | (48,578,208 | ) | - | ||||||||||||||
Income Tax (benefit)/provision (A) | (40,021,151 | ) | 65,376 | ||||||||||||||
NON-GAAP NET LOSS | $ | (1,076,200 | ) | $ | (17,527,457 | ) | |||||||||||
PER SHARE DATA: | |||||||||||||||||
Net income (loss) per common share, basic | $ | (0.04 | ) | $ | (0.75 | ) | |||||||||||
Net income (loss) per common share, diluted | $ | (0.04 | ) | $ | (0.75 | ) | |||||||||||
Weighted average common shares outstanding, basic | 27,157,883 | 23,334,967 | |||||||||||||||
Weighted average common shares outstanding, diluted | 30,380,694 | 23,334,967 | |||||||||||||||
(A) Non-recurring items | |||||||||||||||||
Manager, Investor Relations
IR@retrophin.com
Source:
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